Phase 1 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older who are able to give signed agreement to take part in the trial.
• People who are willing and able to follow all parts of the trial plan.
• People whose general physical functioning is rated at 0 or 1 on a standard cancer performance scale (meaning they are fully active or have only minor restrictions on physical activity).
• People with a life expectancy of at least 3 months.
• People who have been confirmed by laboratory testing to have advanced solid tumours that have spread or cannot be surgically removed, or certain types of lymphoma (a cancer of the lymphatic system) that have come back or are no longer responding to treatment, and for whom standard life-extending treatments are no longer an option. Eligible lymphoma types include but are not limited to NK/T-cell lymphoma, classic Hodgkin lymphoma, peripheral T-cell lymphoma, and diffuse large B-cell lymphoma.
• People for whom no standard treatment is available, or for whom standard treatment is considered unsuitable or not tolerable by the treating doctor.
• People with or without measurable tumour lesions, including those whose tumours are located in previously treated areas if the cancer has been shown to have progressed there.
• People who are able to provide a tumour tissue sample — either from stored tissue or a newly taken biopsy from a tumour that has not been previously irradiated. People previously treated with certain immunotherapy drugs (anti-PD-1/PD-L1 therapies) must provide a tissue sample taken after that treatment. Bone marrow biopsy may also be required for certain lymphoma types (confirm with trial site).
• People whose heart pumping function is greater than 50% as measured by an echocardiogram or similar scan.
• People whose blood and organ function test results meet specific thresholds, including adequate white blood cell counts, haemoglobin levels (which may be supported by transfusion), platelet counts (which may be supported by transfusion), blood clotting levels, liver enzyme levels, bilirubin levels, and kidney function (confirm with trial site for exact values).
• Female participants who are not pregnant, not breastfeeding, and either are not capable of becoming pregnant (for example, due to menopause or surgical sterilisation) or agree to use highly effective contraception during treatment and for at least 90 days after the last dose.
• Male participants who agree to use contraception during treatment and for at least 90 days after the last dose.

Who may not be able to join:

• People who previously had to stop an immunotherapy treatment (such as anti-PD-1 or anti-PD-L1 therapy, or similar drugs) due to a serious immune-related side effect graded as level 3 or higher.
• People who have received cancer treatment — including experimental treatments — within the past 4 weeks or within 5 half-lives of the drug (whichever is the shorter period), or who have not yet recovered from side effects of previous treatment.
• People who have received CAR-T cell therapy unless at least 6 weeks have passed since that treatment, the cancer has since progressed, no CAR-T cells remain in the blood, and any treatment-related side effects have resolved to a mild level.
• People who have received palliative radiotherapy within 2 weeks before starting the trial, or who still have side effects from radiation, or who have had radiation-related lung inflammation.
• People with uncontrolled pain caused by their tumour.
• People who have received a live vaccine within 30 days before the first trial dose. This includes vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid. Certain nasal flu vaccines are also not permitted. Non-live COVID-19 vaccines or boosters must not be given within 30 days before the first dose or during the first cycle of treatment.
• People who are currently taking part in another clinical trial involving an experimental drug or device within 4 weeks or 5 half-lives of that drug, whichever is shorter.
• People who have had a bone marrow, stem cell, or solid organ transplant from another person within the past 5 years.
• People who have a diagnosed immune deficiency condition, or who are taking high-dose steroid medications or other immune-suppressing treatments within 7 days before the first trial dose.
• People who have had another primary cancer within the past 2 years, with some exceptions such as certain treated skin cancers or early-stage cervical or breast cancers, or cancers that are stable, not requiring treatment, and considered clinically insignificant.
• People with known severe allergic reactions to the components of the trial treatment.
• People who have an active autoimmune disease that has required systemic medical treatment within the past 2 years. Hormone or gland replacement therapies are generally not considered a reason for exclusion (confirm with trial site).
• People who have a history of non-infectious lung inflammation that required steroid treatment, or who currently have lung inflammation.
• People who have an active infection that requires systemic treatment within 2 weeks before the first trial dose.
• People with significant heart problems, including poorly controlled high blood pressure, unstable chest pain, a heart attack or stroke within the past 6 months, certain abnormal heart rhythms, or specific abnormalities in heart electrical measurements (confirm with trial site for exact thresholds).
• People who have had major surgery within 4 weeks before the first trial dose and have not yet adequately recovered.
• People who are unable to swallow oral medications, or who have a condition that affects the absorption of medicines taken by mouth.
• People who have any condition, treatment history, or test result that the treating doctor believes could interfere with trial results or with the person's ability to safely complete the trial.
• People with a known psychiatric condition or substance use disorder that could prevent full participation in the trial, including active major depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, or a history of suicidal or homicidal thoughts or attempts.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period and up to 90 days after the last dose.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month.
• People who have cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal disease).
• People with spinal cord compression that has not been definitively treated, or where treatment occurred but stability has not been confirmed for at least 2 weeks before the first dose.
• People who have taken antibiotic medicines by mouth or intravenously within 2 weeks before the first dose (except for low-dose preventive antibiotics).
• People with active tuberculosis.
• People taking certain medications known to strongly interact with the way the trial drugs are processed by the body, if those medications cannot be stopped or changed before starting the trial (confirm with trial site for the specific list of affected drugs).
• People with a history of not following medical treatment plans, or who are unable to give informed consent.

Important: Always verify eligibility with the trial site directly before applying.